SERVICE REP, C/U,INTELIJET, 120V 4350H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-04-28 for SERVICE REP, C/U,INTELIJET, 120V 4350H manufactured by Smith & Nephew, Inc.-endoscopy Div.

Event Text Entries

[178366] Pump was set at approximately 60-70 milli-meters of mercury and was pumping at a much higher rate. The pt's shoulder became swollen and red. The pressure setting of the pump was dropped to approximately 20-30 milli-meters of mercury, but the unit continued to pump at a high rate. The surgery was completed with only a short delay. The pt did not experience any post-op injuries or complications. There was only a small amount of swelling in the shoulder.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1643264-2000-00018
MDR Report Key276075
Report Source07
Date Received2000-04-28
Date of Report2000-04-28
Date of Event2000-03-30
Date Added to Maude2000-05-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSTEVE JACKSON
Manufacturer Street3600 NW 138TH
Manufacturer CityOKLAHOMA CITY OK 73134
Manufacturer CountryUS
Manufacturer Postal73134
Manufacturer Phone4059363000
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSERVICE REP, C/U,INTELIJET, 120V
Generic NameARTHROSCOPIC IRRIGATION PUMP
Product CodeHRT
Date Received2000-04-28
Model Number4350H
Catalog Number4350H
Lot Number*
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key267213
ManufacturerSMITH & NEPHEW, INC.-ENDOSCOPY DIV
Manufacturer Address160 DASCOMB RD ANDOVER MA 01810 US
Baseline Brand NameSERVICE REP, C/U, INTELIJET, 120V
Baseline Generic NameARTHROSCOPIC IRRIGATION PUMP
Baseline Model No4350H
Baseline Catalog No4350H
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2000-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.